Spots Global Cancer Trial Database for Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma
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Trial Identification
Brief Title: Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma
Official Title: A Phase 1b, Open Label, Global, Multicenter, Dose Determination, Randomized Dose Expansion Study to Determine the Maximum Tolerated Dose, Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of Iberdomide (CC-220) in Combination With R-CHOP-21 and CC-99282 in Combination With R-CHOP-21 for Subjects With Previously Untreated Aggressive B-cell Lymphoma
Study ID: NCT04884035
Conditions
Study Description
Brief Summary: This is a Phase 1b study consisting of 2 parts: a dose escalation (Part 1) of CC-220 or CC-99282 added to the standard R-CHOP-21 regimen for first-line treatment of a-BCL. The dose escalation (Part 1) will consist of 2 parallel arms in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP-21); CC-220 and R-CHOP-21 or CC-99282 and R-CHOP-21. Part 1 will be followed by a randomized dose expansion (Part 2) with CC-220 and/or CC-99282 at the Recommended Phase 2 Dose (RP2D) in combination with R-CHOP-21. A polatuzumab-R-CHP regimen in combination with CC-220 or CC-99282 will be explored with the addition of a new cohort only after the RP2D for the CC-220 and/or CC-99282 and R-CHOP-21 combination has been defined.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic - Arizona, Scottsdale, Arizona, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Mayo Clinic Jacksonville - PPDS, Jacksonville, Florida, United States
University Of Kansas Medical Center, Kansas City, Kansas, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
University of Nebraska - Fred and Pamela Buffet Center, Omaha, Nebraska, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
MD Anderson Cancer Center, Houston, Texas, United States
Local Institution - 501, Adelaide, South Australia, Australia
Local Institution - 503, Perth, , Australia
Local Institution - 502, Waratah, , Australia
Local Institution - 702, Athens, , Greece
General Hospital of Athens "Laiko", Athens, , Greece
Local Institution - 701, Athens, , Greece
Local Institution - 703, Patras, , Greece
Georgios Papanikolaou General Hospital of Thessaloniki, Thessaloniki, , Greece
Local Institution - 300, Seoul, , Korea, Republic of
Local Institution - 302, Seoul, , Korea, Republic of
Local Institution - 301, Seoul, , Korea, Republic of
Local Institution - 601, Gdansk, , Poland
MCM Krakow - PRATIA - PPDS, Krakow, , Poland
Centrum Medyczne Pratia Poznan, Poznan, , Poland
Local Institution - 0706, Poznan, , Poland
Local Institution - UNK0706, Poznan, , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie, Slomniki, , Poland
Local Institution - 602, Warsaw, , Poland
Local Institution - 604, Wroclaw, , Poland
Hospital Universitari Germans Trias i Pujol ICO Badalona, Barcelona, , Spain
Local Institution - 204, Madrid, , Spain
H. Virgen de la Victoria, Málaga, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca, Salamanca, , Spain
Local Institution - 403, Taichung, , Taiwan
Local Institution - 402, Taichung, , Taiwan
Local Institution - 400, Taipei, , Taiwan
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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